Europe — EMA
Levosimendan Stada
GNH USA supplies Levosimendan Stada (Levosimendan), a calcium sensitizer / inotropic agent for acute decompensated heart failure and cardiogenic shock.
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What is Levosimendan?
Levosimendan, the active ingredient in Levosimendan Stada, is a calcium sensitizer / inotropic agent presented as an intravenous solution for intravenous use. It treats acute decompensated heart failure in hospitalized adults and may be employed in cardiogenic shock in certain jurisdictions within the EU market.
GNH USA supplies Levosimendan Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide.
What is Levosimendan used for?
Levosimendan is used in the management of acute heart failure syndromes where enhanced cardiac contractility is required.
Acute decompensated heart failure: improves cardiac output and relieves pulmonary congestion. Cardiogenic shock (off‑label in some jurisdictions): provides hemodynamic support when conventional therapy is insufficient. Acute heart failure following myocardial infarction: stabilises haemodynamics while other therapies take effect.
What are the side effects of Levosimendan?
Levosimendan may be associated with several adverse reactions that clinicians monitor during therapy.
Common Side Effects: - Hypotension: reduction in systemic blood pressure. - Headache: mild to moderate intensity. - Nausea: occasional gastrointestinal upset. - Tachycardia: elevated heart rate. - Flushing: transient warmth and redness of skin. - Arrhythmias: non‑life‑threatening rhythm changes.
Serious or Rare Side Effects: - Severe hypotension: marked drop in blood pressure requiring intervention. - Ventricular arrhythmias: potentially life‑threatening rhythm disturbances. - Myocardial ischemia: reduced coronary blood flow. - Anaphylactic reactions: rare hypersensitivity. - Liver enzyme elevation: abnormal hepatic function tests. - Electrolyte disturbances: significant shifts in potassium or magnesium levels.
What precautions apply to Levosimendan?
When using Levosimendan, several safety considerations should be observed.
Monitor blood pressure: watch for excessive hypotension. Observe cardiac rhythm: detect arrhythmias promptly. Adjust dose in renal or hepatic impairment: consider reduced clearance. Avoid in severe hypotension: contraindicated if systolic pressure is very low. Use cautiously with other vasodilators: risk of additive blood pressure effects. Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.
What does Levosimendan interact with?
Levosimendan can interact with other medicines, requiring careful management.
Major Interactions (Avoid): - Concurrent strong vasodilators (e.g., nitroglycerin): may cause profound hypotension. - Potent CYP450 inhibitors (e.g., ketoconazole): increase levosimendan plasma levels. - Other inotropes with arrhythmogenic potential: heighten risk of serious arrhythmias.
Moderate Interactions (Monitor Closely): - Beta‑blockers: may blunt therapeutic effect. - Diuretics: enhance electrolyte shifts. - ACE inhibitors or ARBs: additive blood pressure lowering. - Calcium channel blockers: possible synergistic vasodilation. - Digitalis glycosides: monitor for toxicity.
Frequently asked questions
What is Levosimendan Stada used for?+
How does levosimendan work?+
What is the usual dose of Levosimendan Stada?+
Is Levosimendan safe during pregnancy or breastfeeding?+
How do I order Levosimendan Stada from GNH USA?+
How does Levosimendan compare with other inotropes?+
What are the storage and handling requirements for Levosimendan Stada?+
How is Levosimendan administered?+
What are the most serious risks associated with Levosimendan?+
Who should not receive Levosimendan?+
Product details
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